Regeneron Pharmaceuticals and Sanofi announced that the FDA has accepted for Priority Review the supplemental Biologics License Application (sBLA) for Dupixent (dupilumab) in adolescent patients 12 to 17 years of age with moderate-to-severe atopic dermatitis, whose disease was inadequately controlled with topical therapies or for whom topical treatment was medically inadvisable. Currently, there are no FDA-approved systemic biologic medicines to treat adolescents with moderate-to-severe atopic dermatitis.
The target action date for the FDA decision is March 11, 2019.
The sBLA is supported by data from a pivotal Phase 3 trial evaluating the efficacy and safety of Dupixent monotherapy in adolescent patients with moderate-to-severe atopic dermatitis, which were presented at the European Academy of Dermatology and Venereology in September 2018.
Dupixent works by inhibiting interleukin-4 and interleukin-13 (IL-4 and IL-13) signaling, which is one of the important contributors to Type 2 inflammation, a systemic response known to play a role in moderate-to-severe atopic dermatitis.
Dupixent is currently approved in the U.S. as a treatment for adults with moderate-to-severe atopic dermatitis whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable; and as add-on maintenance treatment for patients 12 years and older with moderate-to-severe asthma with an eosinophilic phenotype or with oral corticosteroid-dependent asthma.
In 2016, the FDA granted Breakthrough Therapy designation for Dupixent for the treatment of moderate-to-severe (adolescents 12 to 17 years of age) and severe (children six months to 11 years of age) atopic dermatitis not well controlled on topical prescription medications.
Dupixent is also approved for use in certain adult patients with moderate-to-severe atopic dermatitis in countries of the European Union, and other countries including Canada and Japan. In the U.S., more than 60,000 adult patients with atopic dermatitis have been prescribed Dupixent to date.
The safety and efficacy of Dupixent in adolescents with atopic dermatitis have not been fully evaluated by any regulatory authority.
Dupilumab Development Program
Regeneron and Sanofi are also studying dupilumab in a broad range of clinical development programs for diseases driven by allergic and other Type 2 inflammation, including pediatric (six months to 11 years of age) atopic dermatitis (Phase 3), pediatric asthma (Phase 3), chronic rhinosinusitis with nasal polyps (Phase 3), eosinophilic esophagitis (Phase 2/3), grass allergy (Phase 2) and peanut allergy (Phase 2). A future trial is planned for chronic obstructive pulmonary disease.
Dupixent is also being studied in combination with REGN-3500, which targets IL-33. These potential uses are investigational and the safety and efficacy have not been evaluated by any regulatory authority. Dupilumab was discovered using Regeneron’s proprietary VelocImmune technology that yields optimized fully human antibodies, and is being jointly developed by Regeneron and Sanofi under a global collaboration agreement.
(Source: Regeneron Pharmaceuticals, Inc.)